Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 3

Conditions: Colitis, Ulcerative; Crohn Disease

Treatments: Drug: Placebo to tulisokibart; Drug: Tulisokibart

Study type: Interventional

Funder types: Industry

Identifiers

NCT06651281

2024-513533-20 (Registry Identifier)

7240-011

U1111-1306-6970 (Other Identifier)

Details and patient eligibility

About

Researchers want to learn more about tulisokibart (also known as MK-7240) in an extension study. Tulisokibart is a medicine designed to treat active, moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). An extension study is a type of study where people who received tulisokibart in certain other studies for CD or UC (called a parent study) may be able to join this study. The goals of this study are to learn about the safety of tulisokibart over time in people with CD or UC, and if people tolerate it.

Enrollment: 1,380 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has participated in a qualifying tulisokibart Phase 2 or Phase 3 parent study for CD or UC
• The investigator determines that the participant derives clinical benefit from continued study intervention based upon clinical evaluations performed during their parent study
• A participant assigned female sex at birth is not breastfeeding during the study intervention period and for at least 14 weeks after the last dose of study intervention
• A participant of childbearing potential (POCBP) is not pregnant and has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention
• A POCBP uses an acceptable contraceptive method, or adheres to penile-vaginal intercourse abstinence as their preferred and usual lifestyle (abstinent on a long-term and persistent basis)

Exclusion criteria

• Has prematurely discontinued study intervention in their parent study
• Has received any protocol-specified prohibited medications during their parent study
• Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,380 participants in 4 patient groups

Group 1: Low Dose Unblinded

Experimental group

Description:

Participants receive a low dose subcutaneous (SC) tulisokibart regimen.

Treatment:

Drug: Tulisokibart

Group 2: High Dose Unblinded

Experimental group

Description:

Participants receive a high dose SC tulisokibart regimen.

Treatment:

Drug: Tulisokibart

Group 3: High Dose Blinded

Experimental group

Description:

Participants receive a blinded high dose SC tulisokibart regimen.

Treatment:

Drug: Tulisokibart

Group 4: Low Dose Blinded

Experimental group

Description:

Participants receive a blinded low dose SC tulisokibart regimen.

Treatment:

Drug: Tulisokibart

Drug: Placebo to tulisokibart